An Open Parallel Study to Determine the Optimum Dosing Schedule for AS-101 in AIDS/ARC Patients - Tabular View

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00002266 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	An Open Parallel Study to Determine the Optimum Dosing Schedule for AS-101 in AIDS/ARC Patients
Official Title ^ICMJE	An Open Parallel Study to Determine the Optimum Dosing Schedule for AS-101 in AIDS/ARC Patients
Brief Summary	To compare AS-101 dosing schedules (once a week; 3 times a week; 5 times a week; or 5 times per week on alternate weeks) on the effect on clinical immunology and virus burden in AIDS or AIDS related complex (ARC) patients.
Detailed Description
Study Phase
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Open Label
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: AS-101
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria Concurrent Medication: Allowed: Standard therapy for infections. Acyclovir. Ganciclovir. Allowed only with permission of Wyeth-Ayerst medical monitor: Zidovudine (AZT). Immunomodulators. Specific therapy for malignancies (including Kaposi's sarcoma). Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Evidence of severe liver dysfunction (serum albumin < 3 g/dl, SGOT or SGPT > 5 x upper limit of normal, prothrombin time > 15 seconds), or gastrointestinal, renal, respiratory, endocrine, hematologic, cardiovascular system abnormalities or psychiatric disorder other than abnormalities secondary to AIDS or AIDS related complex (ARC). Evidence of AIDS-related central nervous system involvement. Disseminated Kaposi's sarcoma. Concurrent Medication: Excluded without permission of Wyeth-Ayerst medical monitor: Zidovudine (AZT). Immunomodulators. Specific therapy for malignancies (including Kaposi's sarcoma). Patients with the following are excluded: Evidence of major system abnormalities other than abnormalities secondary to AIDS or AIDS related complex. Concomitant conditions as specified in Patient Exclusion Co-existing Conditions. Unlikely or unable to comply with the requirements of the protocol. Prior Medication: Excluded within 4 weeks of study entry: Systemic antiviral agents. Immunosuppressive agents. Immune stimulators such as BCG vaccine, isoprinosine, or other immunomodulators. Patients must: Have a diagnosis of AIDS or AIDS related complex (ARC). Demonstrate intolerance or refusal to take zidovudine (AZT). Provide written informed consent.
Gender	Both
Ages	18 Years to 60 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00002266
Responsible Party
Study ID Numbers ^ICMJE	045B, 753A-103-US
Study Sponsor ^ICMJE	Wyeth
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	December 1990
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP